We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Andrea L Kossler, Stanford University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01927406
First Posted: August 22, 2013
Last Update Posted: August 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andrea L Kossler, Stanford University
  Purpose
The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.

Condition Intervention Phase
Thyroid Eye Disease Ocular Hypertension Glaucoma Drug: Prostaglandin Analog Drug: Timolol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.

Resource links provided by NLM:


Further study details as provided by Andrea L Kossler, Stanford University:

Primary Outcome Measures:
  • Change from baseline in appearance of facial periorbital region at 12 months. [ Time Frame: 0 and 12 months ]

Secondary Outcome Measures:
  • Change from baseline in Hertel exophthalmometry at 12 and 24 months. [ Time Frame: 0 and 24 months ]
  • Change from baseline in intraocular pressure at 12 and 24 months. [ Time Frame: 0 and 24 months ]
  • Change from baseline in appearance of facial periorbital region at 24 months. [ Time Frame: 0 and 24 months ]

Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prostaglandin Analog vs Timolol
In this group, with thyroid eye disease and increased intraocular pressure in both eyes, prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye. Timolol 0.5% eye drop will be administered topically in second, control eye, two times a day.
Drug: Prostaglandin Analog
The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.
Other Names:
  • Bimatoprost
  • Travoprost Z
  • Tafluprost
  • Latanoprost
Drug: Timolol
Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.
Other Name: Timolol maleate 0.5%
Experimental: Prostaglandin Analog
In this group, with thyroid eye disease and increased intraocular pressure in only one eye Prostaglandin Analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one, affected eye.
Drug: Prostaglandin Analog
The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.
Other Names:
  • Bimatoprost
  • Travoprost Z
  • Tafluprost
  • Latanoprost

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild or moderate to severe thyroid eye disease in one or both eyes
  • age > 18 years
  • informed consent
  • intraocular pressure > 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes
  • not on current prostaglandin analog intraocular pressure lowering therapy

Exclusion Criteria:

  • sight threatening thyroid eye disease
  • children < 18 years old
  • patients that are not compliant with treatment or follow-up
  • patients already on prostaglandin analog treatment
  • patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up
  • patients that cannot tolerate prostaglandin analog treatment.
  • patients with bilateral thyroid eye disease and elevated intraocular pressures that cannot tolerate treatment with timolol or an alternative intraocular pressure lowering medication such as trusopt, combigan, cosopt.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927406


Contacts
Contact: Barbara Bartlett 650-724-9259 bbartlet@stanford.edu

Locations
United States, California
Stanford Hospital and Clinics Not yet recruiting
Stanford, California, United States, 94304
Contact: Barbara Bartlett    650-724-9259    bbartlet@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrea L. Kossler, M.D. Stanford University
  More Information

Responsible Party: Andrea L Kossler, M.D., Stanford University
ClinicalTrials.gov Identifier: NCT01927406     History of Changes
Other Study ID Numbers: 26654
First Submitted: August 16, 2013
First Posted: August 22, 2013
Last Update Posted: August 22, 2013
Last Verified: August 2013

Keywords provided by Andrea L Kossler, Stanford University:
Thyroid Eye Disease
Graves' Disease
Prostaglandin Analogues

Additional relevant MeSH terms:
Thyroid Diseases
Ocular Hypertension
Eye Diseases
Graves Ophthalmopathy
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Timolol
Latanoprost
Bimatoprost
Travoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents